Nutritional Supplement For Women - Patent 7998500

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United States Patent: 7998500


































 
( 1 of 1 )



	United States Patent 
	7,998,500



 Squashic
,   et al.

 
August 16, 2011




Nutritional supplement for women



Abstract

 A composition for the nutritional supplementation of women and a method
     of administering a composition designed for the nutritional
     supplementation of women is described. In accordance with one embodiment
     of the present invention, such a composition comprises vitamin A, vitamin
     B.sub.1, vitamin B.sub.2, vitamin B.sub.6, vitamin B.sub.12, folic acid,
     vitamin D.sub.3, vitamin C, vitamin E, niacin, copper, magnesium, zinc,
     and iron. In accordance with another embodiment of the present invention,
     a method of administering a composition designed for the nutritional
     supplementation of women comprises the step of administering a
     composition comprising vitamin A, vitamin B.sub.1, vitamin B.sub.2,
     vitamin B.sub.6, vitamin B.sub.12, folic acid, vitamin D.sub.3, vitamin
     C, vitamin E, niacin, copper, magnesium, zinc, and iron.


 
Inventors: 
 Squashic; Steven A. (Scotch Plains, NJ), Hudy; Kevin M. (Hoboken, NJ), Purdy; David C. (Tinton Falls, NJ) 
 Assignee:


Vertical Pharmaceuticals, Inc.
 (Sayreville, 
NJ)





Appl. No.:
                    
11/197,760
  
Filed:
                      
  August 4, 2005





  
Current U.S. Class:
  424/439  ; 424/451; 424/464; 424/466; 424/474; 514/351; 514/52; 514/904; 514/905
  
Current International Class: 
  A61K 9/20&nbsp(20060101); A61K 47/10&nbsp(20060101); A61K 9/28&nbsp(20060101); A61K 9/48&nbsp(20060101)
  
Field of Search: 
  
  




















 424/451,464,630,641,643,646,439 514/52,167,249,251,276,351,355,458,474,566,567,725,904,905
  

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 Other References 

Magnesium factsheet , [online] Office of dietary supplements, National institute of Health, Jan. 2005, Retrieved from the Internet URL: A
http://web.archive.org/web/20050212015808/http://ods.od.nih.gov/factsheet- s/magnesium.asp. cited by examiner.  
  Primary Examiner: Lundgren; Jeffrey S.


  Assistant Examiner: Rao; Savitha


  Attorney, Agent or Firm: Maldjian Law Group LLC
Maldjian, Esq.; John P.



Claims  

What is claimed is:

 1.  A dosing formulation for a composition, the dosing formulation comprising a single dosage formulation of the composition, wherein the composition consists of: about 2100
IUs to about 4200 IUs of vitamin A, about 2 mg to about 4 mg of vitamin B1, about 3.4 mg to about 6.8 mg of vitamin B2, about 10 mg to about 20 mg of vitamin B6, about 15 mcg to about 30 mcg of vitamin B12, about 1.25 mg to about 2.5 mg of folic acid,
about 310 IUs to about 630 IUs of vitamin D3, about 120 mg to about 240 mg of vitamin C, about 20 IUs to about 40 IUs of vitamin E, about 10 mg to about 20 mg of niacin, about 1 mg to about 2 mg of copper, about 15 mg to about 30 mg of magnesium, about
10 mg to about 20 mg of zinc and about 50 mg to about 100 mg of iron.


 2.  A dosing formulation of a composition, the dosing formulation comprising a single dose formulation of the composition, wherein the composition consists of: about 2,100 IUs of vitamin A, about 2 mg of vitamin B1, about 3.4 mg of vitamin B2,
about 10 mg of vitamin B6, about 15 mcg of vitamin B12, about 1.25 mg of folic acid, about 315 IUs of vitamin D3, about 120 mg of vitamin C, about 20 IUs of vitamin E, about 10 mg of niacin, about 1 mg of copper, about 15 mg of magnesium, about 10 mg of
zinc and about 50 mg of iron.


 3.  The dosing formulation of claim 1, wherein the single dosage formulation is selected from the group consisting of a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, a powder, an effervescent tablet, a hard
gelatin capsule, and a soft gelatin capsule.


 4.  The dosing formulation of claim 3, wherein the single dosage formulation comprises an enteric coating.


 5.  The dosing formulation of claim 2, wherein the single dosage formulation is selected from the group consisting of a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, a powder, an effervescent tablet, a hard
gelatin capsule, and a soft gelatin capsule.


 6.  The dosing formulation of claim 5, wherein the single dosage formulation comprises an enteric coating.


 7.  The dosing formulation of claim 1, wherein the single dosage formulation comprises a liquid suspension.


 8.  The dosing formulation of claim 1, wherein the single dosage formulation comprises a food product.


 9.  The dosing formulation of claim 2, wherein the single dosage formulation comprises a liquid suspension.


 10.  The dosing formulation of claim 2, wherein the single dosage formulation comprises a food product.


 11.  A method, comprising the step of administering to an individual a composition consisting of about 2100 IUs to about 4200 IUs of vitamin A, about 2 mg to about 4 mg of vitamin B1, about 3.4 mg to about 6.8 mg of vitamin B2, about 10 mg to
about 20 mg of vitamin B6, about 15 mcg to about 30 mcg of vitamin B12, about 1.25 mg to about 2.5 mg of folic acid, about 310 IUs to about 630 IUs of vitamin D3, about 120 mg to about 240 mg of vitamin C, about 20 IUs to about 40 IUs of vitamin E, about
10 mg to about 20 mg of niacin, about 1 mg to about 2 mg of copper, about 15 mg to about 30 mg of magnesium, about 10 mg to about 20 mg of zinc and about 50 mg to about 100 mg of iron.


 12.  A method, comprising the step of administering to an individual a composition consisting of about 2,100 IUs of vitamin A, about 2 mg of vitamin B1, about 3.4 mg of vitamin B2, about 10 mg of vitamin B6, about 15 mcg of vitamin B12, about
1.25 mg of folic acid, about 315 IUs of vitamin D3, about 120 mg of vitamin C, about 20 IUs of vitamin E, about 10 mg of niacin, about 1 mg of copper, about 15 mg of magnesium, about 10 mg of zinc and about 50 mg of iron. 
Description  

BACKGROUND OF THE INVENTION


 1.  Field of the Invention


 Embodiments of the present invention generally relate to nutritional supplements and in particular to nutritional supplements for use by women.


 2.  Description of the Related Art


 Nutrition plays a critical role in maintaining good health, especially in women during child bearing years.  Prescription multi-vitamins/multi-mineral nutritional supplements are often needed for improving the nutritional status of women prior
to conception, throughout pregnancy and in the post natal period for both lactating and non-lactating mothers.  Pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods in processes in the lifetime of a
woman.


 Specifically, vitamin and mineral needs are almost universally increased during these natural processes.  These increased needs are almost always due to elevated metabolic demand, increased plasma volume, increased levels of blood cells,
decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins.


 Research has suggested that optimizing specific nutrients before, during and after physiological processes of pregnancy and lactation can have a profound, positive and comprehensive impact upon the overall wellness of the mother and of the
developing and newborn child, as well as, the safety and health of the mother.


 Thus, there is a need for a nutritional supplement to be used in improving the nutritional status of women prior to conception, throughout pregnancy and in the post natal period for both lactating and non-lactating mothers.


SUMMARY OF THE INVENTION


 The present invention relates to nutritional supplements for women during pre-pregnancy and post-pregnancy in both lactating and non-lactating conditions.  The nutritional supplement comprises a source of vitamin A, a source of vitamin B1, a
source of vitamin B2, a source of vitamin B6, a source of vitamin B12, folic acid, vitamin D3, vitamin C, vitamin E and niacin, and a source of minerals including copper, magnesium, zinc and iron.


 The nutritional supplement can be made in a variety of forms, such as the following pharmaceutical compositions: a pill, a tablet, a caplet, a capsule, a chewable tablet, a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, a
soft gelatin capsule, a powder, a liquid suspension, and a food product.  One skilled in the art would recognize there are also other viable ways for delivering the nutritional supplement to a user. 

DETAILED DESCRIPTION


 It is understood that the embodiments of the present invention are not limited to the particular methodologies, protocols, solvents and reagents, and the like, described herein as they may vary.  It is also to be understood the terminology used
herein is used for the purpose of describing particular embodiments only and not intended to limit the scope of the present invention.  It must also be noted that as used herein and in the appended claims, the singular form "a," "an" and "the" include
the plural reference unless the context clearly dictates otherwise.  Thus, for example, a reference to "a vitamin" is a reference to one or more vitamins and includes equivalents thereof know to those skilled in the art and so forth.


 Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skilled in the art to which this invention belongs.  Preferred methods, devices and materials are described,
although any methods and materials similar or equivalent to those described herein could be used in the practice or testing of the present invention.  All references cited herein are incorporated by reference herein in there entirety.


 The term "disease state" as used herein, may comprise any state in which one or more organs or components of an organism malfunction.  The term includes "disease state" may refer to any deterioration of any component of a body.  The term
"disease state" may refer to any deficiency of any compound necessary for the maintenance or function of any component of any organism.  The term "disease state" may refer to any condition in which a body contains toxins, produced by microorganisms that
infect the body or by body cells through faulty metabolism or absorbed from an external source.


 The term "disease states" may be adverse states caused by any diet, any virus, or any bacteria.  "Disease states" may comprise disorders associated with pregnant females such as for example, osteomalacia and preeclampsia and disorders associated
with a fetus such as, for example, neurotube defects and various fetal abnormalities.  "Disease states" may comprise any pulmonary disorder such as, for example, bronchitis, bronchiectasis, atelectasis, pneumonia, diseases caused by inorganic dust,
diseases caused by organic dust, any pulmonary fibrosis, and pleurisy.  "Disease states" may comprise any hematological/oncological disorders such as, for example, anemia, hemophilia, leukemia, lymphoma.


 A "disease state" may comprise any cancer such as, for example, breast cancer, lung cancer, prostate cancer, pancreatic cancer, liver cancer, stomach cancer, testicular cancer, ovarian cancer, skin cancer, cancer of the brain, cancer of the
mouth, cancer of the throat, and cancer of the neck.  "Disease states" may comprise any disorder of the immune system such as, for example, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related complex, infection by any strain of any Human
Immunodeficiency Virus (HIV), and other viruses and pathogens such as bacteria.


 A "disease state" may comprise any cardiovascular disorders such as, for example, arterial hypertension, orthostatic hypotension, arteriolosclerosis, coronary artery disease, cardiomyopathy, any arrhythmia, any valvular heart disease,
endocarditis, pericardial disease, any cardiac tumor, any aneurism, and any peripheral vascular disorder.  "Disease states" may comprise any hepatic/biliary disorders such as, for example, jaundice, hepatic steatosis, fibrosis, cirrhosis, hepatitis, any
hepatic granuloma, any liver tumor, cholelithiasis, cholecystitis, and choledocholithiasis.


 The term "physiologically stressful state," as used herein, comprises any state of an organism in which the organism faces one or more physiological challenges.  A "physiologically stressful state" may comprise pre-pregnancy, pregnancy,
lactation, or conditions in which an organism faces physiological challenges related to for example, elevated metabolic demand, increased plasma volume, or decreased concentrations of nutrient-binding proteins.  A "physiologically stressful state" may
result from one or more disease states.


 The term "subject" as used herein comprises any and all organisms and includes the term "patient." "Subject" may refer to a human or any other animal.  "Subject" may also refer to a fetus.


 Proper nutrition is essential for maintaining health and preventing diseases.  Adequate nutrition is especially critical during for example, nutritionally volatile or physiologically stressful.  Such as periods comprising for example,
pre-pregnancy, pregnancy, lactation, or a disease state.  Vitamin and mineral needs are almost universally increased throughout these periods.  Increased needs during physiologically stressful states such as pre-pregnancy, pregnancy, or lactation, for
example, may result from elevated metabolic demand, increased plasma volume, increased quantities of circulating red blood cells, decreased concentrations of nutrients, and decreased concentrations of nutrient-binding protein such as, serum ferritin,
maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinal binding protein, transferritin high density lipoprotein-apolipoprotein A1, folic acid binding protein, and 25-hydrooxy vitamin D binding
protein.


 In one embodiment, the nutritional supplement comprises about 2,100 IUs of vitamin A, about 2 mg of vitamin B1, about 3.4 mg of vitamin B2, about 10 mg of vitamin B6, about 15 mcg of vitamin B12, about 1.25 mg of folic acid, about 315 IUs of
vitamin D3, about 120 mg vitamin C, about 20 IUs of vitamin E, about 10 mg of niacin, about 1 mg of copper, about 15 mg of magnesium, about 10 mg of zinc and about 50 mg of iron.


 In another embodiment the inactive ingredients include croscarmellosesodium, microcrystalline cellulose, calcium phosphate, stearic acid, magnesium stearate, silica, povidone, hydroxypropyl methylcellulose, titanium dioxide, FD&C red number 40.


 The nutritional supplement can be made in a variety of forms, such as pharmaceutical compositions (e.g., tablet, powder, suspension, liquid, capsule, and gel), nutritional beverages, puddings, confections (e.g., candy), ice cream, frozen
confections and novelties or non-baked, extruded food products such as bars.


 In another embodiment, the ingredients of the nutritional supplement can be administered separately, just by incorporating certain components (e.g., bitter tasting ones) into a capsule or tablet and the remaining ingredients provided as a powder
or nutritional bar.  A preferred form of nutritional supplement is a multi-vitamin/mineral with iron tablet specially formulated for women pre-pregnancy, during pregnancy and post-pregnancy.  The nutritional supplement can be formulated for single or
multiple daily administration, preferably one bisected tablet daily or as prescribed by a physician.


 The embodiments of the present invention further pertain to therapeutic methods for managing nutrition of women during pre-pregnancy, pregnancy and post-pregnancy.  The nutritional supplement can be administered to a woman to mitigate reduced
amounts of nutrition and increase the healthiness of an unborn and a newborn.


 Vitamin A is a family of fat-soluble compounds that play an important role in vision, bone growth, reproduction, cell division, and cell differentiation (in which a cell becomes part of the brain, muscle, lungs, etc.).  Vitamin A helps regulate
the immune system, which helps prevent or fight off infections by making white blood cells that destroy harmful bacteria and viruses.  Vitamin A also may help lymphocytes, a type of white blood cell, fight infections more effectively.  Vitamin A promotes
healthy surface linings of the eyes and the respiratory, urinary, and intestinal tracts.  When those linings break down, it becomes easier for bacteria to enter the body and cause infection.  Vitamin A also helps maintain the integrity of skin and mucous
membranes, which also function as a barrier to bacteria and viruses.


 Vitamin E, a fat-soluble vitamin, is an antioxidant vitamin involved in the metabolism of all cells.  It protects vitamin A and essential fatty acids from oxidation in the body cells and prevents breakdown of body tissues.


 Vitamin D3 is a naturally occurring bodily substance that many believe exert a protective effect in multiple sclerosis--both in the development of the disease and in limiting its progression.  It is naturally produced in the skin in response to
sunlight but is also present in certain foodstuffs (particularly oily fish).  Vitamin D3 is a type of steroid hormone and among other things, a powerful mediator of immune function.


 Vitamin D3 is best known for it's effects on calcium metabolism.  Proper levels are necessary to maintain bone mineral density and serum (blood) calcium levels.  This is especially true among the very young where it is used to treat rickets and
in combination with vitamin A for the treatment of osteoporosis in the elderly, particularly post menopausal women who are often subject to fractures due to loss of bone density.


 In studies, Vitamin D3 has been found helpful against autoimmunity for the down-regulation of Th1 and up-regulation of Th2 cells.  It has also been shown to regulate the neurotrophins NGF (Nerve Growth Factor), NT-3 (NeuroTrophin 3) and NT-4. 
In addition, Vitamin D3 has also been found to promote differentiation and cell death in neuroblastoma (brain tumor) cell lines as well as cancers in general.


 Vitamin C is a water-soluble, antioxidant vitamin.  It is important in forming collagen, a protein that gives structure to bones, cartilage, muscle, and blood vessels.  Vitamin C also aids in the absorption of iron, and helps maintain
capillaries, bones, and teeth.  As a water-soluble antioxidant, vitamin C is in a unique position to "scavenge" aqueous peroxyl radicals before these destructive substances have a chance to damage lipids.  It works along with vitamin E, a fat-soluble
antioxidant, and the enzyme glutathione peroxidase to stop free radical chain reactions.  Vitamin C can enhance the body's resistance to an assortment of diseases, including infectious disorders and many types of cancer.  It strengthens and protects the
immune system by stimulating the activity of antibodies and immune system cells such as phagocytes and neutrophils.  Vitamin C contributes to a variety of other biochemical functions.  These include the biosynthesis of the amino acid carnitine and the
catecholamines that regulate the nervous system.  It also helps the body to absorb iron and to break down histamine.  Although vitamin C is found in every cell, it is especially useful in key parts of the body.  These include the blood, the skin, the
nervous system, the teeth and bones and glands such as the thymus, adrenals and thyroid.


 Vitamin B1, also known as thiamin, helps fuel your body by converting blood sugar into energy.  It keeps the mucous membranes healthy and is essential for nervous system, cardiovascular and muscular function.  Vitamin B1 (thiamin) is essential
for the metabolism of carbohydrates to produce energy and for normal nerve and heart function.


 Niacin, vitamin B3 is required for cell respiration, helps in the release of energy and metabolism of carbohydrates, fats, and proteins, proper circulation and healthy skin, functioning of the nervous system, and normal secretion of bile and
stomach fluids.  It is used in the synthesis of sex hormones, treating schizophrenia and other mental illnesses, and a memory-enhancer.  Niacin given in pharmaceutical dosage improves the blood cholesterol profile, and has been used to clear the body of
organic poisons, such as certain insecticides.


 Folic acid is a water-soluble vitamin in the B-complex group.  Folic acid works along with vitamin B12 and vitamin C to help the body digest and utilize proteins and to synthesize new proteins when they are needed.  It is necessary for the
production of red blood cells and for the synthesis of DNA.  Folic acid also helps with tissue growth and cell function.  In addition, it helps to increase appetite when needed and stimulates the formation of digestive acids.  Folic acid supplements may
be used in the treatment of disorders associated with folic acid deficiency and may also be part of the recommended treatment for certain menstrual problems and leg ulcers.


 Vitamin B6 is a water-soluble vitamin that exists in three major chemical forms: pyridoxine, pyridoxal, and pyridoxamine.  It performs a wide variety of functions in the body and is essential for good health.  For example, vitamin B6 is needed
for more than 100 enzymes involved in protein metabolism.  It is also essential for red blood cell metabolism.  The nervous and immune systems need vitamin B6 to function efficiently, and it is also needed for the conversion of tryptophan to niacin.


 The body needs vitamin B6 to make hemoglobin.  Hemoglobin within red blood cells carries oxygen to tissues.  Vitamin B6 also helps increase the amount of oxygen carried by hemoglobin.  A vitamin B6 deficiency can result in a form of anemia that
is similar to iron deficiency anemia.


 Vitamin B6 also helps maintain your blood glucose (sugar) within a normal range.  When caloric intake is low your body needs vitamin B6 to help convert stored carbohydrate or other nutrients to glucose to maintain normal blood sugar levels.


 Vitamin B12, a water-soluble vitamin, is also called cobalamin because it contains the metal cobalt.  This vitamin helps maintain healthy nerve cells and red blood cells.  It is also needed to help make DNA, the genetic material in all cells.


 Magnesium is the fourth most abundant mineral in the body, and is essential to good health.  Approximately 50% of total body magnesium is found in the bone.  The other half is found predominantly inside cells of body tissues and organs.  Only 1%
of magnesium is found in blood, but the body works very hard to keep blood levels of magnesium constant.  Magnesium is needed for more than 300 biochemical reactions in the body.  It helps maintain normal muscle and nerve function, keeps heart rhythm
steady, supports a healthy immune system, and keeps bones strong.  Magnesium also helps regulate blood sugar levels, promotes normal blood pressure, and is known to be involved in energy metabolism and protein synthesis.  Magnesium may play a role in
preventing and managing disorders such as hypertension, cardiovascular disease, and diabetes.


 Zinc is vital for the healthy working of many of the body's systems.  Zinc plays a crucial role in growth and cell division where it is required for protein and DNA synthesis, in insulin activity, in the metabolism of the ovaries and testes, and
in liver function.  As a component of many enzymes, zinc is involved in the metabolism of proteins, carbohydrates, lipids and energy.  Zinc helps with the healing of wounds and is a vital component of many enzyme reactions.  It is also important for
healthy skin and is essential for a healthy immune system and resistance to infection.


 Iron is an essential nutrient that carries oxygen and forms part of the oxygen-carrying proteins, hemoglobin in red blood cells and myoglobin in muscle.  Iron is also a structural component at the catalytic site of a large number of enzymes
covering a wide array of diverse metabolic functions.  These include neurotransmitter synthesis and function, phagocyte antimicrobial activity, hepatic detoxification systems, and synthesis of DNA, collagen and bile acids.


 Copper is needed for normal growth and health.  Copper is also needed to help the body use iron.  It is also important for nerve function, bone growth, and to help the body use sugar.


 While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.


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DOCUMENT INFO
Description: 1. Field of the Invention Embodiments of the present invention generally relate to nutritional supplements and in particular to nutritional supplements for use by women. 2. Description of the Related Art Nutrition plays a critical role in maintaining good health, especially in women during child bearing years. Prescription multi-vitamins/multi-mineral nutritional supplements are often needed for improving the nutritional status of women priorto conception, throughout pregnancy and in the post natal period for both lactating and non-lactating mothers. Pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods in processes in the lifetime of awoman. Specifically, vitamin and mineral needs are almost universally increased during these natural processes. These increased needs are almost always due to elevated metabolic demand, increased plasma volume, increased levels of blood cells,decreased concentrations of nutrients, and decreased concentrations of nutrient-binding proteins. Research has suggested that optimizing specific nutrients before, during and after physiological processes of pregnancy and lactation can have a profound, positive and comprehensive impact upon the overall wellness of the mother and of thedeveloping and newborn child, as well as, the safety and health of the mother. Thus, there is a need for a nutritional supplement to be used in improving the nutritional status of women prior to conception, throughout pregnancy and in the post natal period for both lactating and non-lactating mothers.SUMMARY OF THE INVENTION The present invention relates to nutritional supplements for women during pre-pregnancy and post-pregnancy in both lactating and non-lactating conditions. The nutritional supplement comprises a source of vitamin A, a source of vitamin B1, asource of vitamin B2, a source of vitamin B6, a source of vitamin B12, folic acid, vitamin D3, vitamin C, vitamin E and niacin, and a source of minerals